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    Senior Director Regulatory Affairs Strategy - Boston, United States - EPM Scientific

    EPM Scientific
    EPM Scientific Boston, United States

    3 weeks ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Our client, a clinical stage biotech company, is seeking an experienced and dynamic Director of Regulatory Affairs to join their team. This exciting opportunity offers the chance for someone with clinical regulatory lead experience and Oncology experience to take on a leadership role within this rapidly growing organization.

    Responsibilities:

    Lead interactions with Health Authorities and partners

    Ensure cross-functional alignment among stakeholders involved during key steps across multiple projects simultaneously

    Provide preparation of submission to global health authorities including IND, BLA, CTA, Orphan Drug Designation.

    Assist project leaders by providing guidance regarding US/EU/ROW biocompatibility requirements, testing strategy/design/etc.

    -Review study protocols and clinical study reports

    Qualifications:

    Bachelor's or Master's degree in relevant field

    10+ years' experience working within the biopharma industry

    -Understanding of Oncology Cell Therapy and Biologics

    Clinical development knowledge required



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